Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation
David Brühlmann - CMC Development Leader, Biotech C-level Advisor, Business Strategist
The Go-to Podcast for Biotech Scientists Who Want to Master Biopharma CMC Development and Biomanufacturing.**TOP 10 LIFE SCIENCES PODCAST**Are you ready to simplify bioprocess development and scale with confidence to reduce time to market?Are you feeling overwhelmed by the complexity and guesswork of biologics development and biomanufacturing?Do you wish you had more time to enjoy the beauty of science, without worrying about failing your cell culture process development and commercialization?There's a way to simplify and streamline so you can remove complexity, skip trials and errors, deliver your groundbreaking therapy to clinics and market without delay, and still enjoy every single step.I'm David Brühlmann, a biotech entrepreneur and strategic advisor who partners with C-level biopharma leaders to tackle one of our industry's biggest challenges: reducing manufacturing costs to make lifesaving therapies accessible to more patients worldwide.Through engaging conversations with industry pioneers and practical insights from the trenches, this podcast tackles the critical challenges in bioprocess CMC development and manufacturing of recombinant proteins and cell and gene therapy products. We cut through the complexity so you can:Master bioprocess development with confidence and clarityExcel at scale-up and manufacturing of biologicsTransform your innovative therapy and manufacturing technology into market-ready solutions fasterOptimize manufacturing costs without compromising qualityMake data-driven decisions that reduce the risk of failureI can’t wait to help you do biotech the smart way.Grab a cup of coffee and your favorite notebook and pen. Now is the time to take your bioprocessing game to the next level.Ready to transform your biomanufacturing journey? Let's dive in!Next Steps:Book a free call to reduce biomanufacturing costs and make lifesaving therapies more accessible: https://bruehlmann-consulting.com/call🧬 Ready to accelerate your IND timeline? Get the proven CMC Dashboard that's guided successful mAb programs from chaos to submission: https://stan.store/SmartBiotech/p/cmc-dashboard-for-biotech-foundersAccelerate biologics development with expert guidance: https://bruehlmann-consulting.comFor sponsorship opportunities, contact us at hello@bruehlmann-consulting.comVisit the Website: https://smartbiotechscientist.comEmail us: hello@bruehlmann-consulting.com
Episodes
Mentioned books
May 30, 2024 • 19min
58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls w/ Matthias Müllner - Part 2
Dive into the realm of biotech with our latest episode as we unravel the enigma of Quality by Design (QbD) with Matthias Müllner, CEO of & Co-Founder bespark*bio, a company empowering viral vector-based medicines.Discover how integrating QbD principles early in your development cycle can revolutionize your approach to producing safe, high-quality products consistently. From understanding critical quality attributes to designing robust manufacturing processes, we illuminate the transformative potential of QbD.Key Takeaways:Harnessing QbD principles empowers biotech companies to design quality into processes, fostering a deeper understanding of critical parameters and ensuring product consistency—a game-changer in the industry's quest for reliability.By adopting a phased approach to process development rooted in QbD, companies can streamline experimentation, minimize resource expenditure, and accelerate time-to-market, amplifying efficiency by up to 40%.Embracing innovation, such as machine learning and digitalization, holds the key to unlocking new horizons in CMC development, paving the way for a future where creativity and regulatory compliance converge seamlessly.Tune in to learn how a solid CMC strategy can be the cornerstone of your biotech product's success and ensure you avoid common mistakes that could derail your project.Connect with Matthias Müllner:LinkedIn: https://www.linkedin.com/in/matthias-muellnerNext Step:Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentSupport the show
May 28, 2024 • 17min
57: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls w/ Matthias Müllner - Part 1
Join us for an insightful episode as we dive into the world of bioprocess CMC development strategies with Matthias Müllner, CEO of & Co-Founder bespark*bio, a company empowering viral vector-based medicines.Matthias shares his wealth of knowledge on avoiding common pitfalls in developing robust Chemistry, Manufacturing, and Controls (CMC) strategies. He also emphasizes the critical elements that ensure your biotech product's success.Key Takeaways:Start Strong: Establishing a comprehensive CMC plan early can prevent costly and time-consuming issues later.Leverage Expertise: Bringing in external CMC consultants early on can bridge knowledge gaps and streamline the development process.Build Internally: Gradually develop in-house CMC capabilities to enhance long-term project viability and attract investor confidence.Tune in to learn how a solid CMC strategy can be the cornerstone of your biotech product's success and ensure you avoid common mistakes that could derail your project.Connect with Matthias Müllner:LinkedIn: https://www.linkedin.com/in/matthias-muellnerNext Step:Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentSupport the show
May 23, 2024 • 15min
56: Cultivated Meat: A Promising Future or an Inevitable Bubble? w/ Steven Lang - Part 2
Is cultivated meat the food of tomorrow or just a passing trend? In this episode, we dive deep with Steven Lang, an expert in the field of cultivated meat. Steven sheds light on the intricate process of creating meat in the lab, the challenges faced, and the potential future of this innovative industry.Key Takeaways:Precision in Analytics: Discover how cutting-edge sensory analytics are crucial for developing cultivated meat that mimics traditional meat's texture and taste.Regulatory Innovation: Learn why the regulatory landscape for cultivated meat is set to revolutionize, benefiting not just food tech but also the biopharmaceutical industry.Future Prospects: Understand the potential pitfalls and the exciting innovations on the horizon, making cultivated meat a game-changer for food and biotech sectors.Tune in to explore whether cultivated meat is the future we’ve been waiting for or just a bubble waiting to burst.Connect with Steven Lang:LinkedIn: https://www.linkedin.com/in/steven-lang-b003406Next Step:Don't miss out on boosting your bioprocess development strategy! Schedule your complimentary assessment to propel your success: https://bruehlmann-consulting.com/assessmentSupport the show
May 21, 2024 • 23min
55: Cultivated Meat: A Promising Future or an Inevitable Bubble? /w Steven Lang - Part 1
How can you create an environment suitable for shear-stress-sensitive cells that results in higher cell concentrations and superior quality? Essentially, bionic bioreactors revolutionize this process, changing the game rules with their ability to facilitate bubble-free gas exchange.Join us in this episode as we unravel the groundbreaking innovations in bioreactor technology with our guest, Patrick Bongartz, CEO of BioThrust and the visionary mind behind stress-free cell cultivation.Key Highlights:Discover how bionic bioreactors defy conventional limitations, doubling cell densities even in sensitive cultures like insect cells, promising a paradigm shift in bioproduction efficiency.Unveil the game-changing membrane stirrer technology that not only enhances oxygen transfer but also facilitates precise pH control, revolutionizing process optimization and scalability.Embrace the challenge of disrupting conservative mindsets in the biotech industry.Embark on a journey of scientific breakthroughs and entrepreneurial resilience in this episode.Connect with Patrick Bongartz:Website: https://biothrust.deLinkedin BioThrust: https://www.linkedin.com/company/biothrust-deInstagram: https://www.instagram.com/biothrustPatrick’s LinkedIn: https://www.linkedin.com/in/patrick-bongartz-1106/Next Step:Wondering how to develop biologics and cell & gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentSupport the show
May 16, 2024 • 19min
54: Bionic Bioreactors: The Key to Stress-Free Cell Cultivation w/ Patrick Bongartz - Part 2
How can you create an environment suitable for shear-stress-sensitive cells that results in higher cell concentrations and superior quality? Essentially, bionic bioreactors revolutionize this process, changing the game rules with their ability to facilitate bubble-free gas exchange.Join us in this episode as we unravel the groundbreaking innovations in bioreactor technology with our guest, Patrick Bongartz, CEO of BioThrust and the visionary mind behind stress-free cell cultivation.Key Highlights:Discover how bionic bioreactors defy conventional limitations, doubling cell densities even in sensitive cultures like insect cells, promising a paradigm shift in bioproduction efficiency.Unveil the game-changing membrane stirrer technology that not only enhances oxygen transfer but also facilitates precise pH control, revolutionizing process optimization and scalability.Embrace the challenge of disrupting conservative mindsets in the biotech industry.Embark on a journey of scientific breakthroughs and entrepreneurial resilience in this episode.Connect with Patrick Bongartz:Website: https://biothrust.deLinkedin BioThrust https://www.linkedin.com/company/biothrust-deInstagram: https://www.instagram.com/biothrustPatrick’s LinkedIn: https://www.linkedin.com/in/patrick-bongartz-1106/Next Step:Wondering how to develop biologics and cell & gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentSupport the show
May 14, 2024 • 18min
53: Bionic Bioreactors: The Key to Stress-Free Cell Cultivation w/ Patrick Bongartz - Part 1
How can you provide stress-free cultivation conditions to achieve higher cell concentrations and quality? In a nutshell, bionic bioreactors and thus change bubble-free gas exchange change the game.Join us as we delve into the future of biotech with our guest, Patrick Bongartz, CEO of BioThrust and an expert in innovative bioreactor design.Key Highlights:Unveil the groundbreaking "artificial lung," a marvel of engineering that decouples mixing and gas transfer, enabling stress-free cell growth at unprecedented densities.From scaling issues to cell sensitivity, discover the hurdles that demand ingenious solutions.Explore the critical factors when handling sensitive cell types driving bioreactor evolution.Discover how bionic bioreactors are paving the way for a stress-free future in cell cultivation.Connect with Patrick Bongartz:Website: https://biothrust.deLinkedin BioThrust https://www.linkedin.com/company/biothrust-deInstagram: https://www.instagram.com/biothrustPatrick’s LinkedIn: https://www.linkedin.com/in/patrick-bongartz-1106/Next Step:Wondering how to develop biologics and cell & gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentSupport the show
May 9, 2024 • 27min
52: Unraveling the Complexity of Commercializing Cell and Gene Therapies w/ Wajiha Ali - Part 2
Does the process of commercializing cell and gene therapies seem complex and unclear to you?Dive deep into the groundbreaking world of cell and gene therapies with our guest, Wajiha Ali, a strategy expert who believes in bridging the gap between research and commercialization with data, as we unravel the complexities of bringing life-saving therapies to patients.From cutting-edge technologies to innovative collaboration models, we explore the future landscape of these transformative treatments.You’ll get:An understanding of how partnerships between academic centers, pharma companies, and regulators can decrease development costs and simplify commercialization, resulting in wider accessibility.An investigation into how data analytics, AI, and machine learning can transform supply chains, target selection, commercialization strategies, and regulatory frameworks.A discovery of new methods for equitable therapy access, such as outcome-based pricing, local manufacturing, and the growing role of digital platforms in patient advocacy.Join us on this insightful journey into the future of cell and gene therapies.Connect with Wajiha Ali:LinkedIn: https://www.linkedin.com/in/wajiha-ali-6468454X (Twitter): https://twitter.com/WajihaaliNext Step:Develop biologics and cell & gene therapies with peace of mind. Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment🧬 Stop second-guessing your CMC strategy. Get an investor-ready CMC roadmap in 2 weeks, before mistakes cost you $2M+ and 18 months of delays. Secure your spot at https://stan.store/SmartBiotech/p/dont-let-cmc-kill-your-funding-roundSupport the show
May 7, 2024 • 19min
51: Unraveling the Complexity of Commercializing Cell and Gene Therapies w/ Wajiha Ali - Part 1
Are you finding the path to commercializing cell and gene therapies complex and uncertain?Join us as we explore this intricate landscape with our guest, Wajiha Ali. As a strategy expert who believes in bridging the gap between research and commericalization with data who she will guide us through the challenges, victories, and vital strategies for successfully bringing these cutting-edge therapies to market.Key Highlights:Discover the amplified complexity of cell and gene therapies, from patient referral hurdles to manufacturing site regulations.Explore the crucial commercialization strategies, infrastructure requirements, and the delicate balance between innovation and necessity.Unveil the regulatory scrutiny and stakeholder management intricacies, paving the way for safer, more accessible therapies.Tune in as we navigate the journey from scientific breakthroughs to real-world application, unraveling the complexities shaping the future of healthcare.Connect with Wajiha Ali:LinkedIn: https://www.linkedin.com/in/wajiha-ali-6468454X (Twitter): https://twitter.com/WajihaaliNext Step:Develop biologics and cell & gene therapies with peace of mind. Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentSupport the show
May 2, 2024 • 11min
50: Decode Bioprocess Success: The Art of Stakeholder Management - Part 2
In the second part of "Decode Bioprocess Success: The Art of Stakeholder Management," we delve deeper into the strategies for effective stakeholder management in bioprocess development.Through a step-by-step approach, we explore how to identify, classify, and engage with stakeholders to ensure project success.Key highlights:Learn how to create a stakeholder management plan tailored to the unique needs and interests of each stakeholder group.Discover the power interest grid, a valuable tool for categorizing stakeholders based on their level of influence and interest in the project.Gain insights into developing communication plans that align with stakeholders' preferences and needs.Join us as we uncover the art of stakeholder management and its transformative impact on bioprocess development success. Don't miss out on this episode filled with practical advice and actionable strategies for mastering stakeholder engagement in bioprocess projects.Next Step:Boost your bioprocess strategy! Book your free assessment for success: https://bruehlmann-consulting.com/assessmentSupport the show
Apr 30, 2024 • 17min
49: Decode Bioprocess Success: The Art of Stakeholder Management - Part 1
In this episode, we embark on a journey to uncover the essential strategies for navigating stakeholder relationships in bioprocess CMC development projects.We delve into the critical role of stakeholders in bioprocess development and how their engagement can determine the success or failure of a project. Drawing from real-life experiences and insights, we explore the importance of understanding stakeholder needs, interests, and power dynamics.Discover why stakeholder management is not just a skill but an art form essential for unlocking bioprocess success. Join us as we unravel the complexities of stakeholder engagement and provide actionable tips for mastering this crucial aspect of bioprocess development.Tune in to learn how decoding the dynamics of stakeholder management can lead to triumph in bioprocess projects.Next Step:Boost your bioprocess strategy! Book your free assessment for success: https://bruehlmann-consulting.com/assessmentSupport the show
